Trial Outcomes & Findings for Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001) (NCT NCT03249792)
NCT ID: NCT03249792
Last Updated: 2025-07-24
Results Overview
A DLT is defined as the following toxicities, if related to study treatment: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding); non-hematologic adverse event (AE) ≥Grade 3 (with exceptions); Grade 3 or Grade 4 nonhematologic abnormality; febrile neutropenia Grade 3 or 4; any toxicity causing treatment discontinuation or missing ≥1 dose; any toxicity causing a \>2 week delay initiating pembrolizumab; any elevated aspartate aminotransferase or alanine aminotransferase value that is ≥3× upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2× ULN \& an alkaline phosphatase value that is \<2× ULN with no alternative explanation; any ≥Grade 2 immune-mediated uveitis; Grade 5 toxicity. Per protocol, DLTs were analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more DLTs is reported.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
140 participants
Primary outcome timeframe
Up to ~35 days
Results posted on
2025-07-24
Participant Flow
Arm 3 did not enroll any participants. Per protocol, pharmacokinetic (PK) outcome measures were not analyzed separately for the switch-over treatment arms.
Participant milestones
| Measure |
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy
Participants received MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 µg IT Monotherapy
Participants received MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 µg IT Monotherapy
Participants received MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 µg IT Monotherapy
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 µg IT Monotherapy
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 µg IT Monotherapy
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 µg IT Monotherapy
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 µg IT Monotherapy
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 µg IT Monotherapy
Participants received MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy
Participants were to receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-2 followed by Q3W on Day 1 of Cycle 3 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 µg IT To Arm 2 900 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 300 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 µg IT To Arm 2 2700 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 2700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 5400 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 900 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 7700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 15000 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Arms 1, 2, and 4
STARTED
|
1
|
1
|
1
|
2
|
3
|
3
|
6
|
4
|
6
|
2
|
13
|
11
|
18
|
13
|
0
|
4
|
8
|
14
|
7
|
6
|
3
|
3
|
3
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
|
Arms 1, 2, and 4
Treated
|
1
|
1
|
1
|
2
|
3
|
3
|
6
|
4
|
6
|
2
|
13
|
11
|
16
|
13
|
0
|
4
|
8
|
14
|
7
|
6
|
3
|
3
|
3
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Arms 1, 2, and 4
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Arms 1, 2, and 4
NOT COMPLETED
|
1
|
1
|
1
|
2
|
3
|
3
|
6
|
4
|
6
|
2
|
13
|
11
|
18
|
13
|
0
|
4
|
8
|
14
|
7
|
6
|
3
|
3
|
3
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Switch Over Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
|
Switch Over Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Switch Over Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy
Participants received MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 µg IT Monotherapy
Participants received MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 µg IT Monotherapy
Participants received MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 µg IT Monotherapy
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 µg IT Monotherapy
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 µg IT Monotherapy
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 µg IT Monotherapy
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 µg IT Monotherapy
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 µg IT Monotherapy
Participants received MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy
Participants were to receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-2 followed by Q3W on Day 1 of Cycle 3 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Participants received MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 µg IT To Arm 2 900 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 300 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 µg IT To Arm 2 2700 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 2700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 5400 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 900 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 7700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 15000 µg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Arms 1, 2, and 4
Death
|
1
|
1
|
0
|
2
|
3
|
2
|
2
|
4
|
2
|
1
|
7
|
7
|
12
|
7
|
0
|
4
|
4
|
12
|
6
|
4
|
2
|
3
|
1
|
1
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Arms 1, 2, and 4
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
4
|
0
|
2
|
1
|
4
|
3
|
5
|
3
|
0
|
0
|
3
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Arms 1, 2, and 4
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Arms 1, 2, and 4
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Switch Over Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Switch Over Period
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
1
|
0
|
1
|
|
Switch Over Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)
Baseline characteristics by cohort
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=18 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=14 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=6 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
0 to 17 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
18 to 64 years
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
2 Participants
n=193 Participants
|
4 Participants
|
2 Participants
|
9 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=2 Participants
|
6 Participants
n=102 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=138 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
93 Participants
n=4 Participants
|
|
Age, Customized
65 to 84 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
2 Participants
n=193 Participants
|
2 Participants
|
0 Participants
|
4 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=138 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
44 Participants
n=4 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
2 Participants
|
1 Participants
|
7 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=138 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
3 Participants
n=193 Participants
|
4 Participants
|
1 Participants
|
6 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=2 Participants
|
7 Participants
n=102 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=138 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
6 Participants
|
2 Participants
|
13 Participants
n=19 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=2 Participants
|
7 Participants
n=102 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=138 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
140 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
6 Participants
|
2 Participants
|
13 Participants
n=19 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=2 Participants
|
7 Participants
n=102 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=138 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
140 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to ~35 daysPopulation: All allocated participants who received ≥1 dose of study treatment, who were observed for DLTs for up to 35 days after the first dose of assigned treatment, and had data available for this outcome. Per protocol, DLTs were analyzed separately for the switch-over treatment arms.
A DLT is defined as the following toxicities, if related to study treatment: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding); non-hematologic adverse event (AE) ≥Grade 3 (with exceptions); Grade 3 or Grade 4 nonhematologic abnormality; febrile neutropenia Grade 3 or 4; any toxicity causing treatment discontinuation or missing ≥1 dose; any toxicity causing a \>2 week delay initiating pembrolizumab; any elevated aspartate aminotransferase or alanine aminotransferase value that is ≥3× upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2× ULN \& an alkaline phosphatase value that is \<2× ULN with no alternative explanation; any ≥Grade 2 immune-mediated uveitis; Grade 5 toxicity. Per protocol, DLTs were analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more DLTs is reported.
Outcome measures
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=15 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=6 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 μg IT To Arm 2 900 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 300 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 μg IT To Arm 2 2700 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 2700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 5400 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 900 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
n=2 Participants
Qualified participants who received MK 2118 7700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 15000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience One or More Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to ~65 monthsPopulation: All allocated participants who received ≥1 dose of study treatment. Per protocol, safety was analyzed separately for the switch-over treatment arms.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, safety was analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more AEs is reported.
Outcome measures
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=16 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=14 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=6 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 μg IT To Arm 2 900 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 300 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 μg IT To Arm 2 2700 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 2700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 5400 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 900 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
n=2 Participants
Qualified participants who received MK 2118 7700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 15000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
13 Participants
|
11 Participants
|
16 Participants
|
12 Participants
|
4 Participants
|
8 Participants
|
14 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to ~27 monthsPopulation: All allocated participants who received ≥1 dose of study treatment. Per protocol, tolerability was analyzed separately for the switch-over treatment arms.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, tolerability was analyzed separately for the switch-over treatment arms. The number of participants who discontinued study treatment due to an AE is reported.
Outcome measures
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=16 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=14 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=6 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 μg IT To Arm 2 900 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 300 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 μg IT To Arm 2 2700 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 2700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 5400 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 900 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
n=2 Participants
Qualified participants who received MK 2118 7700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 15000 μg IT + Pembrolizumab 200 mg IV
n=1 Participants
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)Population: The subset of participants who complied with the protocol and had MK-2118 Cmin data available. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Cmin of MK-2118 was defined as the minimum concentration of MK-2118 observed in plasma. Blood samples were collected pre-dose and at specified timepoints post dose for estimation of MK-2118 Cmin. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Outcome measures
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=14 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=12 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=12 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=5 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 μg IT To Arm 2 900 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 300 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 μg IT To Arm 2 2700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 2700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 5400 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 900 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 7700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 15000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MK-2118 Minimum Plasma Concentration (Cmin)
|
2 ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
2 ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
3 ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
3 ng/mL
Geometric Coefficient of Variation 17
|
7 ng/mL
Geometric Coefficient of Variation 70
|
6 ng/mL
Geometric Coefficient of Variation 104
|
3 ng/mL
Geometric Coefficient of Variation 90
|
8 ng/mL
Geometric Coefficient of Variation 153
|
9 ng/mL
Geometric Coefficient of Variation 105
|
7 ng/mL
Geometric Coefficient of Variation 45
|
8 ng/mL
Geometric Coefficient of Variation 99
|
6 ng/mL
Geometric Coefficient of Variation 178
|
9 ng/mL
Geometric Coefficient of Variation 127
|
10 ng/mL
Geometric Coefficient of Variation 228
|
7 ng/mL
Geometric Coefficient of Variation 142
|
7 ng/mL
Geometric Coefficient of Variation 127
|
8 ng/mL
Geometric Coefficient of Variation 168
|
5 ng/mL
Geometric Coefficient of Variation 107
|
7 ng/mL
Geometric Coefficient of Variation 44
|
44 ng/mL
Geometric Coefficient of Variation 3435
|
11 ng/mL
Geometric Coefficient of Variation 216
|
16 ng/mL
Geometric Coefficient of Variation 212
|
36 ng/mL
Geometric Coefficient of Variation 50
|
32 ng/mL
Geometric Coefficient of Variation 64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)Population: The subset of participants who complied with the protocol and had MK-2118 Cmax data available. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Cmax of MK-2118 was defined as the maximum concentration of MK-2118 observed in plasma. Blood samples were collected pre-dose and at specified timepoints post dose for estimation of MK-2118 Cmax. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Outcome measures
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=14 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=12 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=12 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=5 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 μg IT To Arm 2 900 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 300 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 μg IT To Arm 2 2700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 2700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 5400 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 900 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 7700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 15000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MK-2118 Maximum Plasma Concentration (Cmax)
|
6 ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
75 ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
94 ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
259 ng/mL
Geometric Coefficient of Variation 168
|
685 ng/mL
Geometric Coefficient of Variation 41
|
1303 ng/mL
Geometric Coefficient of Variation 57
|
1142 ng/mL
Geometric Coefficient of Variation 91
|
2329 ng/mL
Geometric Coefficient of Variation 84
|
3170 ng/mL
Geometric Coefficient of Variation 47
|
442 ng/mL
Geometric Coefficient of Variation 7
|
348 ng/mL
Geometric Coefficient of Variation 568
|
1091 ng/mL
Geometric Coefficient of Variation 99
|
1715 ng/mL
Geometric Coefficient of Variation 60
|
1758 ng/mL
Geometric Coefficient of Variation 242
|
790 ng/mL
Geometric Coefficient of Variation 21
|
1530 ng/mL
Geometric Coefficient of Variation 40
|
1630 ng/mL
Geometric Coefficient of Variation 112
|
3032 ng/mL
Geometric Coefficient of Variation 26
|
5441 ng/mL
Geometric Coefficient of Variation 36
|
8407 ng/mL
Geometric Coefficient of Variation 17
|
7168 ng/mL
Geometric Coefficient of Variation 117
|
10637 ng/mL
Geometric Coefficient of Variation 35
|
21763 ng/mL
Geometric Coefficient of Variation 63
|
24117 ng/mL
Geometric Coefficient of Variation 20
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)Population: The subset of participants who complied with the protocol and had MK-2118 AUC0-24 hours data available. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
AUC 0-24 hours of MK-2118 was defined as a measure of MK-2118 exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected pre-dose and at specified timepoints post dose for estimation of MK-2118 AUC0-24 hours. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Outcome measures
| Measure |
Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy
n=1 Participants
Participants received MK-2118 100 μg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 300 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 μg IT Monotherapy
n=1 Participants
Participants received MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 μg IT Monotherapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 μg IT Monotherapy
n=3 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 μg IT Monotherapy
n=4 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 μg IT Monotherapy
n=6 Participants
Participants received MK-2118 20000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 Participants
Participants received MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 Participants
Participants received MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 Participants
Participants received MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=14 Participants
Participants received MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy
n=12 Participants
Participants received MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 5000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 Participants
Participants received MK-2118 10000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=12 Participants
Participants received MK-2118 15000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 Participants
Participants received MK-2118 20000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=5 Participants
Participants received MK-2118 30000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 45000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 60000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 Participants
Participants received MK-2118 90000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 120000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 μg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 Participants
Participants received MK-2118 150000 μg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 μg IT To Arm 2 900 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 300 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 μg IT To Arm 2 2700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 2700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 5400 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 900 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 μg IT To Arm 2 7700 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 7700 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 15000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 10000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 μg IT To Arm 2 15000 μg IT + Pembrolizumab 200 mg IV
Qualified participants who received MK 2118 20000 μg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 μg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MK-2118 Area Under the Concentration-time Curve From 0 to 24 Hours (AUC 0-24 Hours)
|
7 hour*ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
169 hour*ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
314 hour*ng/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
|
420 hour*ng/mL
Geometric Coefficient of Variation 181
|
1484 hour*ng/mL
Geometric Coefficient of Variation 36
|
2777 hour*ng/mL
Geometric Coefficient of Variation 59
|
2959 hour*ng/mL
Geometric Coefficient of Variation 92
|
4478 hour*ng/mL
Geometric Coefficient of Variation 34
|
6210 hour*ng/mL
Geometric Coefficient of Variation 47
|
944 hour*ng/mL
Geometric Coefficient of Variation 13
|
1217 hour*ng/mL
Geometric Coefficient of Variation 187
|
2300 hour*ng/mL
Geometric Coefficient of Variation 78
|
3219 hour*ng/mL
Geometric Coefficient of Variation 50
|
3993 hour*ng/mL
Geometric Coefficient of Variation 190
|
1630 hour*ng/mL
Geometric Coefficient of Variation 18
|
3272 hour*ng/mL
Geometric Coefficient of Variation 41
|
4518 hour*ng/mL
Geometric Coefficient of Variation 74
|
7736 hour*ng/mL
Geometric Coefficient of Variation 26
|
13866 hour*ng/mL
Geometric Coefficient of Variation 31
|
19257 hour*ng/mL
Geometric Coefficient of Variation 6
|
19946 hour*ng/mL
Geometric Coefficient of Variation 19
|
29638 hour*ng/mL
Geometric Coefficient of Variation 67
|
73573 hour*ng/mL
Geometric Coefficient of Variation 51
|
75171 hour*ng/mL
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycles 1, 2, 3, 4, 5 and every 4 cycles thereafter (up to ~2 years) (Arm 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 to 36= 3 weeks)Population: The subset of participants who complied with the protocol and had pembrolizumab Cmin data available. Pembrolizumab Cmin analysis was not planned in Arm 1 (MK-2118 IT monotherapy) or for the switch-over treatment arms, per protocol. For Arm 2 (MK-2118 IT + Pembrolizumab combination) and Arm 4 (MK-2118 SC + Pembrolizumab combination), pembrolizumab Cmin data were not collected.
Cmin of pembrolizumab was defined as the minimum concentration of pembrolizumab observed in plasma. Blood samples were to be collected at specified timepoints for estimation of pembrolizumab Cmin. Per protocol, analysis of pembrolizumab Cmin was not planned in Arm 1 (MK-2118 IT Monotherapy) or for the switch-over treatment arms. For Arm 2 (MK-2118 IT + Pembrolizumab combination) and Arm 4 (MK-2118 SC + Pembrolizumab combination), pembrolizumab Cmin data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 1 MK-2118 300 µg IT Monotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 1 MK-2118 900 µg IT Monotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 1 MK-2118 2700 µg IT Monotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Arm 1 MK-2118 5400 µg IT Monotherapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm 1 MK-2118 7700 µg IT Monotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm 1 MK-2118 10000 µg IT Monotherapy
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Arm 1 MK-2118 15000 µg IT Monotherapy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm 1 MK-2118 20000 µg IT Monotherapy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 4 serious events
Other events: 13 other events
Deaths: 8 deaths
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 6 serious events
Other events: 11 other events
Deaths: 9 deaths
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 13 serious events
Other events: 16 other events
Deaths: 13 deaths
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 6 serious events
Other events: 12 other events
Deaths: 9 deaths
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 2 serious events
Other events: 8 other events
Deaths: 6 deaths
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 2 serious events
Other events: 14 other events
Deaths: 12 deaths
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Switch-over Arm 1 MK-2118 300 µg IT To Arm 2 900 µg IT + Pembrolizumab 200 mg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Switch-over Arm 1 MK-2118 2700 µg IT To Arm 2 2700 µg IT + Pembrolizumab 200 mg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 5400 µg IT + Pembrolizumab 200 mg IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Switch-over Arm 1 MK-2118 900 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Switch-over Arm 1 MK-2118 7700 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 15000 µg IT + Pembrolizumab 200 mg IV
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy
n=1 participants at risk
Participants received MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 µg IT Monotherapy
n=1 participants at risk
Participants received MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 µg IT Monotherapy
n=1 participants at risk
Participants received MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 µg IT Monotherapy
n=2 participants at risk
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 µg IT Monotherapy
n=3 participants at risk
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 µg IT Monotherapy
n=3 participants at risk
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 µg IT Monotherapy
n=6 participants at risk
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 µg IT Monotherapy
n=4 participants at risk
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 µg IT Monotherapy
n=6 participants at risk
Participants received MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 participants at risk
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 participants at risk
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 participants at risk
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=16 participants at risk
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 participants at risk
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 participants at risk
Participants received MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 participants at risk
Participants received MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=14 participants at risk
Participants received MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 participants at risk
Participants received MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=6 participants at risk
Participants received MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 participants at risk
Participants received MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 participants at risk
Participants received MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 participants at risk
Participants received MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 participants at risk
Participants received MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 participants at risk
Participants received MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 µg IT To Arm 2 900 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 300 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 µg IT To Arm 2 2700 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 2700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 5400 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 900 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
n=2 participants at risk
Qualified participants who received MK-2118 7700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 15000 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Death
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site swelling
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Serositis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Mastitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Pneumonia
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Product Issues
Device malfunction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
Other adverse events
| Measure |
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy
n=1 participants at risk
Participants received MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 300 µg IT Monotherapy
n=1 participants at risk
Participants received MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 900 µg IT Monotherapy
n=1 participants at risk
Participants received MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 2700 µg IT Monotherapy
n=2 participants at risk
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 5400 µg IT Monotherapy
n=3 participants at risk
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 7700 µg IT Monotherapy
n=3 participants at risk
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 10000 µg IT Monotherapy
n=6 participants at risk
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 15000 µg IT Monotherapy
n=4 participants at risk
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 1 MK-2118 20000 µg IT Monotherapy
n=6 participants at risk
Participants received MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=2 participants at risk
Participants received MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 participants at risk
Participants received MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=11 participants at risk
Participants received MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=16 participants at risk
Participants received MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy
n=13 participants at risk
Participants received MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy
n=4 participants at risk
Participants received MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=8 participants at risk
Participants received MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=14 participants at risk
Participants received MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=7 participants at risk
Participants received MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=6 participants at risk
Participants received MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 participants at risk
Participants received MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 participants at risk
Participants received MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=3 participants at risk
Participants received MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 participants at risk
Participants received MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
n=4 participants at risk
Participants received MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed by Q3W on Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and received pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
|
Switch-over Arm 1 MK-2118 300 µg IT To Arm 2 900 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 300 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 2700 µg IT To Arm 2 2700 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 2700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 5400 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 900 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 900 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 7700 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV
n=2 participants at risk
Qualified participants who received MK-2118 7700 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 15000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 15000 µg IT + Pembrolizumab 200 mg IV
n=1 participants at risk
Qualified participants who received MK-2118 20000 µg via IT injection in Arm 1 but experienced disease progression switched over to Arm 2 and received combination therapy of MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Swelling face
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site erythema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site oedema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
3/3 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
3/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
4/4 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
23.1%
3/13 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
2/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
2/2 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site pruritus
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site rash
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
23.1%
3/13 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
28.6%
4/14 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Injection site warmth
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Localised oedema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
23.1%
3/13 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 12 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
3/6 • Number of events 8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
4/6 • Number of events 7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
2/2 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
46.2%
6/13 • Number of events 12 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
45.5%
5/11 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
37.5%
6/16 • Number of events 15 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
38.5%
5/13 • Number of events 9 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
21.4%
3/14 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
2/3 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Pyuria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Stoma site irritation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood creatine increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
27.3%
3/11 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Troponin I increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
Troponin increased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
4/16 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
28.6%
4/14 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
3/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
3/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
30.8%
4/13 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
4/16 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour exudation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
21.4%
3/14 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Product Issues
Device malfunction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
30.8%
4/13 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Psychiatric disorders
Sleep disorder
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
31.2%
5/16 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
30.8%
4/13 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
21.4%
3/14 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
2/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
4/6 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
46.2%
6/13 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
46.2%
6/13 • Number of events 7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
42.9%
3/7 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Anisocoria
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Eye irritation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Scleritis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
21.4%
3/14 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
23.1%
3/13 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
37.5%
6/16 • Number of events 7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
37.5%
6/16 • Number of events 7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
31.2%
5/16 • Number of events 6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
23.1%
3/13 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
35.7%
5/14 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
2/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Rectal spasm
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Chills
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
46.2%
6/13 • Number of events 13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
27.3%
3/11 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Early satiety
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Facial pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
66.7%
2/3 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
3/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
2/6 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
38.5%
5/13 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
27.3%
3/11 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
4/16 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
38.5%
5/13 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
2/4 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
4/8 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
35.7%
5/14 • Number of events 5 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
42.9%
3/7 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
3/6 • Number of events 4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
75.0%
3/4 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
100.0%
1/1 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.8%
3/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
2/14 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
18.2%
2/11 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
6.2%
1/16 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
2/8 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.1%
1/14 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
15.4%
2/13 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
1/8 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
33.3%
1/3 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
9.1%
1/11 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
12.5%
2/16 • Number of events 3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
14.3%
1/7 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
16.7%
1/6 • Number of events 2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
25.0%
1/4 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
7.7%
1/13 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
50.0%
1/2 • Number of events 1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/11 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/16 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/13 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/8 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/14 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/7 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/6 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/3 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/4 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/2 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
0.00%
0/1 • Up to ~65 months
All-cause mortality (ACM): All allocated participants; AEs: All allocated participants who received ≥1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, ACM and AEs were analyzed separately for the switch-over treatment arms.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER